BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS

    MDR report key: 15307007 · Received August 26, 2022

    Report

    Report Number
    3003337893-2022-00003
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    July 27, 2022
    Report Date
    August 26, 2022
    Manufacturer
    NEPHROS
    Product Code
    NHV
    UDI-DI
    00896241002541
    PMA / PMN Number
    K153084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEPHROS S100 POINT OF USE IS A SINK WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED ON SINK FAUCETS IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THEIR SINKS AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES AND THE INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NEPHROS S100 POINT OF USE IS A SINK WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED ON SINK FAUCETS IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THEIR SINKS AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. DEVICE EVALUATION: COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES. THE INVESTIGATION OF THE RETURNED FILTERS DETERMINED THAT ONE OF THE INTERNAL FILTER COMPONENTS WERE DAMAGED AND ULTIMATELY ALLOWED UNFILTERED WATER (WITH POSITIVE BACTERIA COUNTS) TO PASS THROUGH THE FILTER. LOT REPRESENTATIVE FILTER SAMPLES WERE TESTED FOR ANY SIGNS OF CHANGE IN FILTER ABILITY TO FUNCTION PROPERLY UNDER THE PUBLISHED PRODUCT SPECIFICATIONS. NO CHANGES OR ISSUES WERE IDENTIFIED. ACTIVE MONITORING OF CUSTOMER PLUMBING SYSTEMS IDENTIFIED PRESSURES SIGNIFICANTLY ABOVE THE PRODUCT AND PLUMBING SPECIFICATION. THE ROOT CAUSE OF THE DAMAGE TO THE INTERNAL FILTER COMPONENTS WAS DETERMINED TO BE CAUSED BY EXCESSIVE PRESSURE AND UNUSUALLY POOR WATER QUALITY/CONDITIONS AT THE FACILITY WHICH STRESSED INTERNAL FILTER COMPONENTS ABOVE AND BEYOND THEIR RECOMMENDED USE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF AN S100 POINT OF USE (70-0280) FILTER ON ONE OF THEIR SINKS. THERE WAS NO REPORTED ADVERSE EVENT. NEPHROS S100 POINT OF USE IS A SINK WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED ON SINK FAUCETS IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THEIR SINKS AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES AND THE INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219011 NEPHROS S100 NHV NEPHROS S100 PI20/0270 00896241002541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown